Coronary Stenosis Treated With Implant of Bioresorbable DevicesREPARA-QALYNCT02854007
Costs, Effectiveness, QALYs, and Efficiency of Bioabsorbable Devices in Daily Clinical Practice
An observational study of Coronary Stenosis Treated With Implant of Bioresorbable Devices, run by Sección Hemodinamica y Cardiologia Intervencionista at 1 site in Spain.
Trial summary
A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Stenosis Treated With Implant of Bioresorbable Devices
- What is being tested?
- Coronary angioplasty with implant of bioresorbable device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 sites.
Who may be able to join
- Age ranging from 18 and 95 years.
- Both sexes.
- Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
- Informed consent signed before participation in the study is started.
Who cannot join
- Pregnant or nursing woman..
- Cardiogenic shock.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital 12 de Octubre
Madrid, Madrid, 28041
Felipe Hernandez, MD, +34 913908440, felipeivus@hotmail.com
Sandra Mayordomo, MD, +34 913908440, sandrinimg@hotmail.com
About this study
Official title: REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry
A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.
Read the detailed description
Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.
Primary objective:
- To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.
Secondary objectives:
- To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
- To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
- To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).
- Being tested
- Coronary angioplasty with implant of bioresorbable device
- Keywords
- Coronary artery disease, Angioplasty, Bioresorbable coronary device, QALY (Quality-Adjusted Life Years)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angioplasty with implant of bioresorbable deviceDevice
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Coronary stenosis treated with Absorb | Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 siteS. Receives: Device: Coronary angioplasty with implant of bioresorbable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
To construct QALYs, the EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension. If a patient dies, the value of EQ-5D is 0 from the date of death.
Measured: 1 year follow-up
Secondary outcomes (1)
"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Stenosis Treated With Implant of Bioresorbable DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sección Hemodinamica y Cardiologia Intervencionista
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Hernandez, MD, Principal investigator, Hospital 12 de Octubre, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854007
- Sponsor's protocol ID
- COR-BVS-2016-01
- Acronym
- REPARA-QALY
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry
- ClinicalTrials.gov ID
- NCT02854007
- Acronym / sponsor ID
- REPARA-QALY / COR-BVS-2016-01
- Keywords
- Coronary artery disease, Angioplasty, Bioresorbable coronary device, QALY (Quality-Adjusted Life Years)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sección Hemodinamica y Cardiologia IntervencionistaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.
Detailed description
Economical evaluation study of the efficiency of Absorb in a cohort of patients with ischemic heart disease who have undergone revascularization with Absorb based on the criteria established according to standard clinical practice. A comparison group without Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own control, and a before-after comparison will be done. This is therefore a prospective, observational cohort study with concurrent data collection.
Primary objective:
- To assess utility (QALYs gained) in patients implanted Absorb in standard clinical practice conditions.
Secondary objectives:
- To assess effectiveness (clinical outcomes) in patients who undergo coronary revascularization with Absorb implantation.
- To assess costs (direct and indirect) derived from coronary revascularization with Absorb implantation.
- To assess efficiency in terms of cost/utility (cost per QALY gained) and cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary stenosis treated with Absorb | – | Device: Coronary angioplasty with implant of bioresorbable devicePatients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 siteS. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease who have undergone percutaneous coronary revascularization with Absorb according to standard clinical practice. One thousand revascularized patients will be recruited at 40 sites.
Key inclusion criteria (4 listed)
- Age ranging from 18 and 95 years.
- Both sexes.
- Coronary revascularization with Absorb for any of the following lesions: de novo, restenosis, segment ST elevation myocardial infarction (STEMI), chronic total occlusion (CTO), trunk, venous graft, or bifurcations.
- Informed consent signed before participation in the study is started.
Key exclusion criteria (3 listed)
- Pregnant or nursing woman..
- Cardiogenic shock.
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angioplasty with implant of bioresorbable devicePercutaneous coronary intervention | Device | Coronary stenosis treated with Absorb |
Primary outcome
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year)
Time frame: 1 year follow-up
To construct QALYs, the EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension. If a patient dies, the value of EQ-5D is 0 from the date of death.
1 secondary outcome
"Target lesion failure", defined as cardiac death, target-vessel myocardial infarction, and target lesion ischemia at any time during the follow-up period.
Time frame: 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Hernandez, MD principal investigator
Hospital 12 de Octubre, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis Treated With Implant of Bioresorbable Devices, run by Sección Hemodinamica y Cardiologia Intervencionista at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe Hernandez, MD (+34-630068923, felipeivus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Adjusted Live Years (QALYs) gained since the first revascularization (the week before revascularization) to the end of follow-up (one year) (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.